ATP/AMP Challenge in Healthy Non-smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159315
Recruitment Status : Withdrawn (no resources available)
First Posted : September 12, 2005
Last Update Posted : June 4, 2015
Duska Scientific Co.
Information provided by:
Imperial College London

Brief Summary:

In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate COPD.

Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3 the effects of adenosine 5`-triphosphate (ATP) or adenosine 5`-monophosphate (AMP) challenge, given in a random order, will be tested.

Condition or disease Intervention/treatment Phase
Asthma COPD Smoking Procedure: Inhalation Challenge with ATP Procedure: Inhalation Challenge with AMP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Adenosine 5`-Triphosphate (ATP) Challenge in Healthy Non-smokers, Current Smokers and Patients With Mild Asthma and Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. PC20 of ATP and AMP
  2. Lung function
  3. Borg score
  4. Impulse oscillometry (IOS)

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy non-smokers (n=12)

    • Normal spirometry
    • Forced expiratory volume in 1 second (FEV1) reversibility of < 15% after inhaled beta2-agonists*
  2. At risk (current smokers) (n=12)*

    • Normal spirometry, chronic symptoms (cough, sputum production)
    • FEV1 reversibility of < 15% after inhaled beta2-agonists* (* = Global Strategy for the Diagnosis, Management, and Prevention of COPD)
  3. Mild steroid-naïve asthma (n=30)

    • FEV1 more than or equal to 80%
  4. Mild-moderate COPD (n=30)

    • FEV1 50-80%

Exclusion Criteria:

  1. Pregnancy, breast-feeding, or planned pregnancy during the study.
  2. Fertile women not using acceptable contraceptive measures, as judged by the investigator
  3. Upper respiratory infection within the last 4 weeks
  4. Subjects who have received research medication within the previous one month
  5. Subjects unable to give informed consent
  6. Any psychiatric condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159315

United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Duska Scientific Co.
Principal Investigator: Sergei A Kharitonov, MD, PhD Imperial College London Identifier: NCT00159315     History of Changes
Other Study ID Numbers: DHTABPT0336
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: August 2008

Keywords provided by Imperial College London:
Healthy Volunteers (smokers)
Healthy Volunteers (Non-smokers)
Asthma Patients
COPD Patients

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases